Prehabilitation Program for Lung and Esophageal Cancers (Boosting Recovery and Activity Through Early Wellness): Protocol for a Nonrandomized Trial.

Abstract

Background: Cancer is the leading cause of death in Canada, responsible for 28.2% of all deaths. Based on surgical candidacy and disease status, both lung and esophageal cancer are treated through surgical resection by a thoracic surgeon. Although surgery contributes to improved outcomes, the 30-day postoperative mortality risks are as high as 10% and 2.8%, respectively. Evidence has shown that prehabilitation is a way in which patients can have improved postoperative outcomes. Prehabilitation is multimodal, often including some form of movement, nutrition, stress management, and smoking cessation. Given the complexity of the health care system, pragmatic trials are important methodological tools to assess internal validity and improve current practice under real-world conditions. Concurrently, using community resources is imperative to keep people active in their community and create sustainable programming.

Objective: The Boosting Recovery and Activity Through Early Wellness (BREATHE WELL) study aims to explore the feasibility, implementation, and preliminary effectiveness of a clinically integrated, community-based, prehabilitation health coaching program. This includes nutrition, smoking cessation, sleep hygiene, and movement for individuals scheduled to undergo surgery for lung or esophageal cancer.

Methods: This is a pilot, nonrandomized, pragmatic, repeated measures, mixed methods trial. We will recruit 32 participants diagnosed with lung or esophageal cancer and are scheduled to undergo surgical resection into the prehabilitation program, with 32 additional participants who decline participation to act as a control group. Participants who agree will then go through an 8-week tailored prehabilitation program (in person or virtual), covering movement, nutrition, stress management, nutrition, goal setting, and smoking cessation. They will complete 6 sessions prior to surgery and then have 4 sessions, 1×/week following surgery. Following the completion of the program, they will have 3 booster sessions via phone or Zoom (Zoom Video Communications). The primary outcome is feasibility: (1) recruitment feasibility-recruitment rate (the number of participants referred per month), enrollment rate (the number of enrolled participants divided by the number of referred participants), reasons for declining, and prehabilitation window (time between consent and surgery); and (2) intervention feasibility-adherence to the movement intervention, attrition, safety, study completion rate, and adverse events. Secondary outcomes include measures of preliminary effectiveness including patient-reported outcomes, such as well-being, fatigue, and functional measures. All measures will be assessed before, during, and after the prehabilitation program.

Results: Enrollment has begun in January 2025, with 2 participants enrolled in the health coaching program. The full study is expected to be completed in approximately 3 years and be published in winter 2027.

Conclusions: This study will inform the feasibility, implementation, and preliminary effectiveness of a clinically integrated, community-based, prehabilitation program in Nova Scotia, Canada, for people scheduled to undergo curative intent surgery for lung and esophageal cancer.

Trial registration: ClinicalTrials.gov NCT06354959; https://clinicaltrials.gov/study/NCT06354959.

International registered report identifier (irrid): PRR1-10.2196/60791.